Medical device recalls Moderate risk

Biomet, Inc. recalls BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Re…

Recall date
September 23, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0212-2026
FDA classification
Class II
Brand / firm
Biomet, Inc.
Sold / distributed
Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA 2025-00166_Initial Distribution History containing the distribution and the identification of the domestic consignees.

Why it was recalled

There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair

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